EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2023) XXX  draft  
ANNEX  
 
ANNEX  
to the  
Commission Regulation .../...  
amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council 
as regard the use of Vitamin A, Alpha -Arbutin and Arbutin and certain substances with 
potential endocrine disrupting properties in cosmetic products    
EN 1  EN ANNEX  
Annexes II , III, V and VI  to Regulation (EC) No 1223/2009 are amended as follows:  
 
(1) In Annex II, the following entry is added:  
 
 
 
 
 
 
 
 
* From … [ OP please insert the date = first day of the month following 12 months after the date of entry into force of this Regulation ] cosmetic 
products containing that substance shall not be placed on the Union market. From … [ OP please insert th e date = first day of the month following 24 
months after the date of entry into force of this Regulation ] cosmetic products containing that substance shall not be made available on the Union 
market’.  
 
(2) Annex III is amended as follows:  
(a) the followin g entries are added:  
Reference 
number  
 Substance identification  Conditions  
Wordings of 
conditions of use 
and warnings  Chemical 
name/INN  Name              
of Common 
Ingredients 
Glossary  CAS number  EC 
number  Product type, 
body parts  Maximum 
concentration in 
ready use 
preparation  Other  
a b c d e f g h i Reference number  Substance identification  
Chemical name/INN  CAS number  EC number  
a b c d 
ʻX [OP: please replace 
with the next consecutive 
number ] 3-(4'-methylbenzylidene) -
camphor*;  
[INCI: 4 -Methylbenzylidene 
Camphor]  36861 -47-9/38102 -62-4 253-242-6/-  
EN 2  EN ‘X [OP: 
please 
replace 
with the 
next 
consecutiv
e number ] Genisteol 4',5,7 -
Trihydroxyisoflav
one*  Genistein  446-72-0  207-174-9   0,007 %     
X [OP: 
please 
replace 
with the 
next 
consecutiv
e number ] Daidzeol 7,4' - 
Dihydroxyisoflavo
ne* Daidzein  486-66-8  207-635-4   0,02 %    
X [OP: 
please 
replace 
with the 
next 
consecutiv
e number ] 5-Hydroxy -2-
(hydroxymethyl) -
4H-pyrane -4-one*  Kojic Acid  501-30-4  207-922-4  Face and hand 
products  1 %   
X [OP: 
please 
replace 
with the 
next 
consecutiv
e number ] (2E,4E,6E,8E) -
3,7-dimethyl -9-
(2,6,6 -
trimethylcyclohexe
n-1-yl)nona -
2,4,6,8 -tetraen -1-
ol** 
 
[(2E,4E,6E,8E) -
3,7-dimethyl -9-
(2,6,6 -
trimethylcyclohexeRetinol  
 
 
 
 
 
 
 
Retinyl Acetate  
 
 
 11103 -57-4/ 
68-26-8 
 
 
 
 
 
 
127-47-9 
 
 
 234-328-2/ 
200-683-7 
 
 
 
 
 
 
204-844-2 
 
 
 (a) Body lotion  
 
(b) other leave -on 
and rinse -off 
products  (a) 0,05 % 
Retinol 
Equivalent (RE)  
 
(b) 0,3 % RE  
 
  For any cosmetic 
product containing 
Retinol, Retinyl 
Acetate or  
Retinyl Palmitate 
the following, 
labelling is 
obligatory: 
‘Contains Vitamin 
A-related 
compounds, which 
contribute to your 
daily intake of  
EN 3  EN n-1-yl)nona -
2,4,6,8 -tetraenyl] 
acetate* * 
 
[(2E,4E,6E,8E) -
3,7-dimethyl -9-
(2,6,6 -
trimethylcyclohexe
n-1-yl)nona -
2,4,6,8 -tetraenyl] 
hexadecanoate**   
 
 
 
Retinyl 
Palmitate   
 
 
 
79-81-2  
 
 
 
201-228-5 Vitamin A’.  
X [OP: 
please 
replace 
with the 
next 
consecutiv
e number ] 4-Hydroxyphenyl -
alpha -D-
glucopyranoside * 
 
 Alpha -Arbutin  
 
 84380 -01-8 617-561-8 (a) Face cream  
(b) Body lotion  (a) 2 %  
(b) 0,5 %  Hydroquinone 
levels shall remain 
as low as possible 
in formulations 
containing alpha-
Arbutin  and shall 
not be higher than 
the unavoidable 
trace level .  
X [OP: 
please 
replace 
with the 
next 
consecutiv
e number ] 4-Hydroxyphenyl -
beta-D-
glucopyranoside * 
 Arbutin  
 497-76-7 207-850-3 Face cream  
 7 % Hydroquinone 
levels shall remain 
as low as possible 
in formulations 
containing Arbutin 
and shall not be 
higher than the 
unavoidable trace 
level .  
* From … [ OP please insert the date = first day of the month following 9 months after the date of entry into force of this Regulation ] cosmetic products 
containing that substance and not complying with the conditions shall not be placed on the Union market. From … [ OP please insert the date = first  
EN 4  EN day of the month following 18 months after the date of entry into force of this Regulation ] cosmetic products containing that substance and not 
complying with the conditions shall not be made available on the Union market.’  
** From … [ OP please insert the date = first day  of the month following 18 months after the date of entry into force of this Regulation ] cosmetic 
products containing that substance and not complying with the conditions shall not be placed on the Union market. From … [ OP please insert the date 
= first da y of the month following 36 months after the date of entry into force of this Regulation ] cosmetic products containing that substance and not 
complying with the conditions shall not be made available on the Union market.’  
 
(3) In Annex V, entries 23 and 2 5 are replaced by the following:  
Refe
renc
e 
num
ber 
 Substance identification  Restrictions  Wordings of 
conditions of use 
and warnings  Chemical name/INN  Name              
of 
Common 
Ingredients 
Glossary  CAS 
number  EC 
number  Product type, 
body parts  Maximum 
concentration in 
ready use 
preparation  Other  
a b c d e f g h i 
‘23 1-(4-Chlorophenyl) -3-
(3,4-
dichlorophenyl)urea* **  Triclocarban  101-20-2 202-924-1 All c osmetic 
products , with the 
exception of 
mouthwash . 0,2 %  Purity criteria:  
3,3',4,4' -
Tetrachloroazobenz
ene ≤ 1 ppm  
 
3,3',4,4' -
Tetrachloroazoxybe
nzene ≤ 1 ppm  
 
Not to be used in 
toothpaste intended 
for children under 6 
years of age.  For toothpaste 
containing 
Triclocarban the 
following labelling 
is obligatory: ‘ Not 
to be used for 
children under 6 
years of age ’.  
EN 5  EN * Cosmetic products containing that substance that do not comply with the conditions may, provided that they comply with the conditions  applicable 
on … [ OP: please insert the date = the day before the date of entry into for ce of this Regulation ], be placed on the Union market until … [ OP: please 
insert the date = the last day of the 8th month after the date of entry into force of this Regulation ] and , if they have already been placed on the market 
before that date, continue to be  made available on the Union market until … [ OP: please insert the date = the last day of the 17th month after the date of 
entry into force of this Regulation ]. 
** For uses other than preservative, see  Annex III , No. 100 .’ 
 
(4) In Annex VI, entry 18 is deleted.  
 25 5-Chloro -2- (2,4- 
dichlorophenoxy) 
phenol*  Triclosan  3380 -34-5 222-182-2 Toothpastes; Hand 
soaps; Body 
soaps/Shower gels; 
Deodorants (non -
spray); Face 
powders and 
blemish 
concealers; Nail 
products for 
cleaning the 
fingernails and 
toenails before the 
application of 
artificial nail 
systems;  0,3 %  Not to be used in 
toothpaste intended 
for children under 3 
years of age.  For toothpaste 
containing Triclosan 
the following 
labelling is 
obligatory: ‘ Not to 
be used for children 
under 3 years of 
age’.